NCT03637972

COMET2 Project 1 Filter Ventilation Study

Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.

Detailed description

This randomized, open label, controlled multi-site study will simulate a "real world" tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products. Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS. Smokers will undergo an in person screening and then a 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. The experimental period will simulate a "real world" environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money. Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial.

Conditions

• Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	Ventilated cigarettes only	Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
OTHER	Unventilated cigarettes only	Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
OTHER	Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems	Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
OTHER	Access to Experimental Marketplace: Unventilated cigarettes + ANDS	Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.

Timeline

• Start date: 2018-10-18
• Primary completion: 2021-12-09
• Completion: 2021-12-09
• First posted: 2018-08-20
• Last updated: 2022-04-29

Locations

2 sites across 1 country: United States